EP3931348C0 - Oligonucleotide formulation method - Google Patents
Oligonucleotide formulation methodInfo
- Publication number
- EP3931348C0 EP3931348C0 EP20705224.2A EP20705224A EP3931348C0 EP 3931348 C0 EP3931348 C0 EP 3931348C0 EP 20705224 A EP20705224 A EP 20705224A EP 3931348 C0 EP3931348 C0 EP 3931348C0
- Authority
- EP
- European Patent Office
- Prior art keywords
- formulation method
- oligonucleotide formulation
- oligonucleotide
- formulation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 108091034117 Oligonucleotide Proteins 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
- C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N5/00—Analysing materials by weighing, e.g. weighing small particles separated from a gas or liquid
- G01N5/02—Analysing materials by weighing, e.g. weighing small particles separated from a gas or liquid by absorbing or adsorbing components of a material and determining change of weight of the adsorbent, e.g. determining moisture content
- G01N5/025—Analysing materials by weighing, e.g. weighing small particles separated from a gas or liquid by absorbing or adsorbing components of a material and determining change of weight of the adsorbent, e.g. determining moisture content for determining moisture content
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
- C07H21/00—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2310/00—Structure or type of the nucleic acid
- C12N2310/30—Chemical structure
- C12N2310/31—Chemical structure of the backbone
- C12N2310/315—Phosphorothioates
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2310/00—Structure or type of the nucleic acid
- C12N2310/30—Chemical structure
- C12N2310/31—Chemical structure of the backbone
- C12N2310/318—Chemical structure of the backbone where the PO2 is completely replaced, e.g. MMI or formacetal
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2310/00—Structure or type of the nucleic acid
- C12N2310/30—Chemical structure
- C12N2310/32—Chemical structure of the sugar
- C12N2310/321—2'-O-R Modification
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2310/00—Structure or type of the nucleic acid
- C12N2310/30—Chemical structure
- C12N2310/32—Chemical structure of the sugar
- C12N2310/323—Chemical structure of the sugar modified ring structure
- C12N2310/3231—Chemical structure of the sugar modified ring structure having an additional ring, e.g. LNA, ENA
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Molecular Biology (AREA)
- General Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Physics & Mathematics (AREA)
- Microbiology (AREA)
- Biophysics (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Plant Pathology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Saccharide Compounds (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP19159353 | 2019-02-26 | ||
PCT/EP2020/054716 WO2020173845A1 (en) | 2019-02-26 | 2020-02-24 | Oligonucleotide formulation method |
Publications (3)
Publication Number | Publication Date |
---|---|
EP3931348A1 EP3931348A1 (en) | 2022-01-05 |
EP3931348C0 true EP3931348C0 (en) | 2023-08-09 |
EP3931348B1 EP3931348B1 (en) | 2023-08-09 |
Family
ID=65729069
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP20705224.2A Active EP3931348B1 (en) | 2019-02-26 | 2020-02-24 | Oligonucleotide formulation method |
Country Status (5)
Country | Link |
---|---|
US (1) | US20210388359A1 (en) |
EP (1) | EP3931348B1 (en) |
JP (1) | JP7503072B2 (en) |
CN (1) | CN113474633A (en) |
WO (1) | WO2020173845A1 (en) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20240018523A1 (en) * | 2020-12-22 | 2024-01-18 | Empirico Inc. | Galnac compositions for improving sirna bioavailability |
WO2023067038A1 (en) | 2021-10-22 | 2023-04-27 | Roche Innovation Center Copenhagen A/S | Process for oligonucleotide purification |
WO2023178144A2 (en) | 2022-03-16 | 2023-09-21 | Empirico Inc. | Galnac compositions for improving sirna bioavailability |
Family Cites Families (35)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
NL9201440A (en) | 1992-08-11 | 1994-03-01 | Univ Leiden | Triantennary cluster glycosides, their preparation and application. |
JP3756313B2 (en) | 1997-03-07 | 2006-03-15 | 武 今西 | Novel bicyclonucleosides and oligonucleotide analogues |
AU9063398A (en) | 1997-09-12 | 1999-04-05 | Exiqon A/S | Oligonucleotide analogues |
US6300319B1 (en) | 1998-06-16 | 2001-10-09 | Isis Pharmaceuticals, Inc. | Targeted oligonucleotide conjugates |
RU2233844C2 (en) | 1999-02-12 | 2004-08-10 | Санкио Компани Лимитед | New nucleoside and oligonucleotide analogues |
US7053207B2 (en) | 1999-05-04 | 2006-05-30 | Exiqon A/S | L-ribo-LNA analogues |
JP4306881B2 (en) | 1999-07-26 | 2009-08-05 | キヤノン株式会社 | Target nucleic acid detection / quantification method by dry fluorescence measurement |
US7100428B1 (en) * | 2002-06-11 | 2006-09-05 | Walter Dziki | Method and device for determination of moisture content and solid state phase of solids using moisture sorption gravimetry and near infrared or raman spectroscopy |
EP2141233B1 (en) | 2002-11-18 | 2016-10-19 | Roche Innovation Center Copenhagen A/S | Antisense design |
EP1495769B1 (en) | 2003-07-11 | 2008-02-27 | LBR Medbiotech B.V. | Mannose-6-phosphate receptor mediated gene transfer into muscle cells |
US20120122801A1 (en) | 2005-01-05 | 2012-05-17 | Prosensa B.V. | Mannose-6-phosphate receptor mediated gene transfer into muscle cells |
AU2007211080B9 (en) | 2006-01-27 | 2012-05-03 | Isis Pharmaceuticals, Inc. | 6-modified bicyclic nucleic acid analogs |
WO2007112753A2 (en) | 2006-04-03 | 2007-10-11 | Santaris Pharma A/S | Pharmaceutical composition comprising anti-mirna antisense oligonucleotides |
US7666854B2 (en) | 2006-05-11 | 2010-02-23 | Isis Pharmaceuticals, Inc. | Bis-modified bicyclic nucleic acid analogs |
ES2389737T3 (en) | 2006-05-11 | 2012-10-31 | Isis Pharmaceuticals, Inc. | 5 'modified bicyclic nucleic acid analogs |
BRPI0716823A2 (en) | 2006-09-15 | 2015-05-26 | Enzon Pharmaceuticals Inc | Polymeric assembly containing positively charged portions |
US9550988B2 (en) | 2006-10-18 | 2017-01-24 | Ionis Pharmaceuticals, Inc. | Antisense compounds |
AU2008260277C1 (en) | 2007-05-30 | 2014-04-17 | Isis Pharmaceuticals, Inc. | N-substituted-aminomethylene bridged bicyclic nucleic acid analogs |
US8278426B2 (en) | 2007-06-08 | 2012-10-02 | Isis Pharmaceuticals, Inc. | Carbocyclic bicyclic nucleic acid analogs |
DK2176280T4 (en) | 2007-07-05 | 2015-07-20 | Isis Pharmaceuticals Inc | 6-Disubstituerede bicykliske nukleinsyreanaloge |
WO2009067647A1 (en) | 2007-11-21 | 2009-05-28 | Isis Pharmaceuticals, Inc. | Carbocyclic alpha-l-bicyclic nucleic acid analogs |
US8501805B2 (en) | 2008-09-24 | 2013-08-06 | Isis Pharmaceuticals, Inc. | Substituted alpha-L-bicyclic nucleosides |
JP5132621B2 (en) | 2009-03-27 | 2013-01-30 | 学校法人慈恵大学 | Nucleic acid quantification method and nucleic acid quantification apparatus |
US9012421B2 (en) | 2009-08-06 | 2015-04-21 | Isis Pharmaceuticals, Inc. | Bicyclic cyclohexose nucleic acid analogs |
EP2580228B1 (en) | 2010-06-08 | 2016-03-23 | Ionis Pharmaceuticals, Inc. | Substituted 2'-amino and 2'-thio-bicyclic nucleosides and oligomeric compounds prepared therefrom |
WO2012109395A1 (en) | 2011-02-08 | 2012-08-16 | Isis Pharmaceuticals, Inc. | Oligomeric compounds comprising bicyclic nucleotides and uses thereof |
EP2742056B2 (en) | 2011-08-11 | 2020-06-10 | Ionis Pharmaceuticals, Inc. | Selective antisense compounds and uses thereof |
WO2013154798A1 (en) | 2012-04-09 | 2013-10-17 | Isis Pharmaceuticals, Inc. | Tricyclic nucleic acid analogs |
JP6452614B2 (en) | 2012-11-15 | 2019-01-16 | ロシュ イノベーション センター コペンハーゲン エーエス | Oligonucleotide conjugate |
RU2018108405A (en) | 2013-01-30 | 2019-02-26 | Ф. Хоффманн-Ля Рош Аг | CARBOHYDRATE AND LNA-OLIGONUCLEOTIDE CONJUGATES |
KR20200090966A (en) | 2013-05-01 | 2020-07-29 | 아이오니스 파마수티컬즈, 인코포레이티드 | Compositions and methods for modulating apolipoprotein c-iii expression |
LT3013959T (en) | 2013-06-27 | 2020-03-10 | Roche Innovation Center Copenhagen A/S | Antisense oligomers and conjugates targeting pcsk9 |
KR102287532B1 (en) | 2014-01-30 | 2021-08-11 | 에프. 호프만-라 로슈 아게 | Poly oligomer compound with biocleavable conjugates |
BR112017005938A2 (en) | 2014-10-10 | 2017-12-12 | Hoffmann La Roche | compounds, compound preparation process, galnac and nucleic acid conjugate preparation process and compound uses |
KR20200042902A (en) * | 2017-07-28 | 2020-04-24 | 셀진 코포레이션 | Method for preparing oligonucleotide compounds |
-
2020
- 2020-02-24 JP JP2021549745A patent/JP7503072B2/en active Active
- 2020-02-24 WO PCT/EP2020/054716 patent/WO2020173845A1/en unknown
- 2020-02-24 EP EP20705224.2A patent/EP3931348B1/en active Active
- 2020-02-24 CN CN202080016654.7A patent/CN113474633A/en active Pending
-
2021
- 2021-08-25 US US17/411,662 patent/US20210388359A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
JP2022522430A (en) | 2022-04-19 |
JP7503072B2 (en) | 2024-06-19 |
WO2020173845A1 (en) | 2020-09-03 |
US20210388359A1 (en) | 2021-12-16 |
EP3931348A1 (en) | 2022-01-05 |
EP3931348B1 (en) | 2023-08-09 |
CN113474633A (en) | 2021-10-01 |
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